miscellaneous software and features
TRANSCRIPT
21 CFR Part 11 The control of inspection information as it applies to the medicalindustry is defined by FDA title 21 Code of Federal Regulations (21CFR Part 11). QC-CALC’s data collection, storage, and reportingadhere to this important standard. Although this option has seen an increase in use by industries other than medical, it can bedisabled for industries not requiring such strict control.
Part 11 Trackable ChangesQC-CALC’s password protected audit functionality automatically triggers when there are:
•Changestothemeasuredvalue •Changestothemeasuredateortime •Changestothenumberoffailscount •Changestothenameofanyfactor(non-measurement
trace field) •Changestothevalueofanyfactor(non-measurement
trace field) •Deletions/undeletionsofindividualpoints •Deletions/undeletionsofrecords(parts) •Remeasurementsofapart. •Additions,removals,ordisplayorderchangesof
assignable causes •Additions,removals,ordisplayorderchangesof
correctiveactions •Printactionsofasignedreport
Part 11 LDAPQC-CALC optionally operates within your Lightweight Directory Access Protocol (LDAP) system where all user accounts and passwordsarestoredatthecompanylevelandareadministeredby the IT department.
Administrative ToolsHistorically,QC-CALChasbeenusedwithinanindividualinspectionmachineasasinglecopyofsoftwarewithindividualsettings.Asmoderninspectiondeviceshavebeenincreasinglyplaced on the internal network, there is now a greater need to sharetheindividualsettingsacrossmultiplePCs.
TheAdministrativeToolwascreatedtodojustthat.ItcentrallycontrolsthesettingsandprivilegesoftheindividualcopiesofQC-CALC running throughout the shop. Through the creation ofgroups,administratorscandefinewhichcopieshaveaccesstothevarioussettingsandfunctionalityinQC-CALC.Thesesettingscan easily be changed from any of the participating copies of QC-CALCwiththeuseofanadministrativepassword.
Maintenance PlansAnnual Maintenance Plans are optional maintenance agreementsthat you purchase with your products and are priced based onthe amount of software you currently own. Maintenance Plansinclude both upgrades to our products as well as premiumsupportviaemail,ourwebsite,orthephone.
UpgradesWhile a Maintenance Plan is in effect, you are entitled to any number of FREE upgrades to your products. Upgrades are definedaschangestothemajororminorversionnumberandareenhancementstothesoftware(i.e.switchingfromversion3.0 to 3.1 or from 3.0 to 4.0).
SupportWhileaMaintenancePlanisineffect,youreceivepremiumsupport for all of your products including phone, email, and website support. Without a Maintenance Plan in effect, you may purchasepremiumsupportcallsviaourwebsite.
NOTE: Email and website support are always FREE regardless of whetherornotyouhaveaMaintenancePlan.
QC-SORTThisnonstatisticalapplicationisusedinconjunctionwithQC-CALC Real-Time to quickly identify bad parts on a multiple-part inspection fixture. QC-Sort makes it easy foryouroperatorstoremoveproblem parts from the fixture by using color coded squares to identify the bad parts. QC-Sortisadjustableandeasilyconfigured to display the physical layout of your parts as they are fixtured.
It does not matter how many features are inspected. If any feature on a part is out of specification, that part is considered a bad part. QC-Sort displays the corresponding rectangle for that part in red. All good parts are displayed in green.
Miscellaneous Software and Features
Please download a 30-day trial version from our website and try it out!
Prolink Corporation148EasternBlvd•Glastonbury,CT06033Phone:860.659.5928Fax:860.633.7309Email: [email protected] www.ProlinkSoftware.com
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Enterprise Report Scheduler™ - ERSTheEnterpriseReportSchedulerprovideshigh-levelsummaryreportingatthefactoryorcorporatelevel.Reportscanbescheduledatregularintervalstocomparethequalitycapability across departments, plants, and multiple locations.
QC-CALC® SPCQC-CALCSPCisourcomprehensivestatisticalprocess control application designed to moni-tor, manage, analyze, and report the results of your inspection data right from your desktop.
SPC Office Buddy™Although QC-CALC SPC is our main QA analysis tool,theSPCOfficeBuddyprovidesafastandeasymethodofmovingyourdatadirectlyintoMinitab®, JMP®, and Excel. Integrating with externalprogramsallowsemployeestolever-age existing software purchases and streamlines acceptance within your organization.
QC-CALC® Real-TimeWrittenin1983,QC-CALCReal-Timeisatthe heart of Prolink’s software suite since it is the central hub of all data collection. This stand-alone program is required by most companies since it collects, analyzes, and reports the inspection results.
Reaction Plan Manager™ (RPM)This ground breaking software package providesproductivitytoolsbeyondSPC.Itallowsyoutocombine measurement data with engineering knowledgetoproduceveryspecificoperatorinstructionsusedformachineadjustments.
QC-Gage®
QC-Gageisdesignedtocollectinspectiondata directly from electronic gages or operator typedvalues.
QA LabQA Lab
EDL / ERS
Enterprise Reporting
SQLDatabase
Corporate Corporate Management
QC-CALC SPC SPC OFFICE BUDDY
QC-CALC Real-Time
Reaction Plan Editor
Reaction Plan ViewerQC-Gage
QC-CALC SPC
FileServer
EnterpriseReports
Six Sigma Analysis / Excel
Real-Time Trends
On DemandSPC Reports
Shop FloorShop Floor
Process Engineer
Shop Personnel
Quality OfficeQuality Office SPC Engineer
SPC Inspector
ProcessAdjustment Reports
CMMs
Parts Are Made Parts Are Inspected
Real-TimeReports
ReactionPlan
Manager
Software Solutions
Prolink offers an entire suite of software solutions to address and automate the data collection and quality analysis tasks performed throughout your organization. As depicted below, the collected datacanthenbesharedateachlevelofyourorganizationusingourvarioussoftwaretools.Thediagramandbriefsummary
explains how each program fits into the big picture. Each color-codedlevelinthediagramhasacorrespondingcoloreddatasheetprovidingthedetailandkeybenefitsoftheproductdescribed.
SPC
How it Works QC-CALCReal-TimereadsCMMandgagedataandsavesittothenetworkdatabasemakingtheresultsavailabletoQC-CALCSPC. QC-CALC SPC opens the same database from your office or other remote location. As data is collected, your SPC plots arecontinuouslyupdatedtoshowyouliveresultsfromtheshopfloor. QC-CALC SPC can then filter the data and run charts and reportsgivingyoufullcontrol.
Reporting Reporting in QC-CALC SPC allows you to analyze the data and printyourchartstoaprinter,printpreview,ortoafile.Thefollowingreporttypesareavailable:
Control Charts •Xbar&Range •Individual&MovingRange
•Xbar&Sigma •MovingAvg.&Range•Median&Range •BivariateAnalysisReport•Individual&Range
Process Charts •ProcessCapability(Cpk) •Correlation&Regression
•ProbabilityPlot •RawDataw/OutlierDetect•ParetoAnalysis •HistogramAnalysis
Attribute Charts •PChart •CChart •NpChart •UChart
Miscellaneous Reports •StatisticalSummary •Non-Conformance
•RawData •GageR&R(RangeandANOVA)•FirstArticle •21CFRPart11AuditReport
QCC filesstored on File Server
SPC Reports
ReadData
SPC Engineer
IntroductionQC-CALC SPC is a complete SPC package that analyzes the data collected by QC-CALC Real-Time. Use QC-CALC SPC’s charts and reports to constantly monitor your process and keep it in control.
QC-CALCSPCoffersawidevarietyofchartsandfunctionstoaidyouranalysisandgiveyouthepowertomakeon-the-spotdeci-sions.Inseconds,QC-CALCSPCgivesyouaprecisepictureofhow your production line is performing with easy-to-use menus.
Key Benefits
Quality Office SPC Process Flow
operation key
•Controlcharts•Processcapabilitycharts•Attributecharts•Abilitytoprintreports
direct to PDF •Abilitytoemailreports•21CFRPart11compliant
•RecordandDimensionfiltering•RemoteReal-Timemonitoring
capability•Multipledatabasegrouping
capability•Built-inreportdesigner•Built-inpasswordprotection
SPC
Report Formats The Real-Time and SPC Reports can be printed to the following file formats:
•PDF •PDF(signedelectronic) •RichTextFormat(RTF) •Excel •ExcelTable •XML •HTML
•Metafile(EMF)Enhanced•MIMEHTML•Multi-MIMEHTML•Bitmap(BMP)•JPEG•TIFF•Text
Monitoring Monitoringallowsyoutowatchthedataliveononecomputer as parts are being inspected on another. As your CMM runs, QC-CALCReal-TimeisupdatingitslivescreenswhileQC-CALCSPC displays the same data in another location. This means you havetheabilitytoseetheconditionofyourinspectedpartsinreal-timefromyourofficeorevenatthemachiningcenter.Youcan monitor a single file, a group of files, or the inspection machineitself.Youcanalsochoosetoviewthedataineitherliveplots or in spreadsheet form.
Dimension Filtering Dimensionfilteringallowsyoutocreateandsavedifferentcombinationsofdimensionfiltersprovidingaquickviewofcritical features. Dynamic dimension filtering allows you to see only features that are trending, out of specification, or out of control.
Trace Fields Extranon-measurementdatavaluesareautomaticallyaddedfromtheinspectionmachineandavailableforlivefiltering.
Record Filtering Recordfilteringallowsyoutoquicklyshowandreportonjustthe data you need at the moment. Dynamic filtering allows the displayedvaluestochangeautomaticallybasedonthepartjustreceived.
Grouping Ifyou’veeverinspectedpartsusingCMMs,VideoCMMs,orhand gages, you understand the problems associated with creating a concise summary report from multiple data sources. Groupingallowsyoutoopenmultiplefilesatthesametimetocreate a full report across inspection equipment. Each file can be displayed in a grid or as plots similar to QC-CALC Real-Time.
21 CFR Part 11 Compliant The features that make QC-CALC so flexible can be controlled usingthebuilt-inAdministrativeTooltoguaranteetotalcontrolof changes. This system includes an audit report showing all password protected changes.
Database Maintenance The basic database maintenance functions included with the software are:
•Merge •Purge •Compact(Removesdeletedrecords) •Restructuringthedatabase
Please download a 30-day trial version from our website and try it out! Prolink Corporation • 860.659.5928 • www.prolinksoftware.com
21 CFR Part 11 The control of inspection information as it applies to the medicalindustry is defined by FDA title 21 Code of Federal Regulations (21CFR Part 11). QC-CALC’s data collection, storage, and reportingadhere to this important standard. Although this option has seen an increase in use by industries other than medical, it can bedisabled for industries not requiring such strict control.
Part 11 Trackable ChangesQC-CALC’s password protected audit functionality automatically triggers when there are:
•Changestothemeasuredvalue •Changestothemeasuredateortime •Changestothenumberoffailscount •Changestothenameofanyfactor(non-measurement
trace field) •Changestothevalueofanyfactor(non-measurement
trace field) •Deletions/undeletionsofindividualpoints •Deletions/undeletionsofrecords(parts) •Remeasurementsofapart. •Additions,removals,ordisplayorderchangesof
assignable causes •Additions,removals,ordisplayorderchangesof
correctiveactions •Printactionsofasignedreport
Part 11 LDAPQC-CALC optionally operates within your Lightweight Directory Access Protocol (LDAP) system where all user accounts and passwordsarestoredatthecompanylevelandareadministeredby the IT department.
Administrative ToolsHistorically,QC-CALChasbeenusedwithinanindividualinspectionmachineasasinglecopyofsoftwarewithindividualsettings.Asmoderninspectiondeviceshavebeenincreasinglyplaced on the internal network, there is now a greater need to sharetheindividualsettingsacrossmultiplePCs.
TheAdministrativeToolwascreatedtodojustthat.ItcentrallycontrolsthesettingsandprivilegesoftheindividualcopiesofQC-CALC running throughout the shop. Through the creation ofgroups,administratorscandefinewhichcopieshaveaccesstothevarioussettingsandfunctionalityinQC-CALC.Thesesettingscan easily be changed from any of the participating copies of QC-CALCwiththeuseofanadministrativepassword.
Maintenance PlansAnnual Maintenance Plans are optional maintenance agreementsthat you purchase with your products and are priced based onthe amount of software you currently own. Maintenance Plansinclude both upgrades to our products as well as premiumsupportviaemail,ourwebsite,orthephone.
UpgradesWhile a Maintenance Plan is in effect, you are entitled to any number of FREE upgrades to your products. Upgrades are definedaschangestothemajororminorversionnumberandareenhancementstothesoftware(i.e.switchingfromversion3.0 to 3.1 or from 3.0 to 4.0).
SupportWhileaMaintenancePlanisineffect,youreceivepremiumsupport for all of your products including phone, email, and website support. Without a Maintenance Plan in effect, you may purchasepremiumsupportcallsviaourwebsite.
NOTE: Email and website support are always FREE regardless of whetherornotyouhaveaMaintenancePlan.
QC-SORTThisnonstatisticalapplicationisusedinconjunctionwithQC-CALC Real-Time to quickly identify bad parts on a multiple-part inspection fixture. QC-Sort makes it easy foryouroperatorstoremoveproblem parts from the fixture by using color coded squares to identify the bad parts. QC-Sortisadjustableandeasilyconfigured to display the physical layout of your parts as they are fixtured.
It does not matter how many features are inspected. If any feature on a part is out of specification, that part is considered a bad part. QC-Sort displays the corresponding rectangle for that part in red. All good parts are displayed in green.
Miscellaneous Software and Features
Please download a 30-day trial version from our website and try it out!
Prolink Corporation148EasternBlvd•Glastonbury,CT06033Phone:860.659.5928Fax:860.633.7309Email: [email protected] www.ProlinkSoftware.com
Distributed By:
Product catalog